Infant formula wars

Scientists dissatisfied with the Food and Drug Administration’s role in failing to regulate a plastics hardener, bisphenol A, are going directly to infant formula manufacturers.

Last week, Environmental Working Group, the advocacy research group that brought to light the presence of bisphenol A in some food products, sent letters to several companies asking them to “immediately repackage formula and canned food to remove this chemical, shown by many studies to cause brain and reproductive system damage in crucial stages of development.”

The letters were sent to the CEOs of some companies that use BPA-based epoxy resin coating to line their formula cans. They include Nestle (Good Start), Ross-Abbott (Similac and Isomil), MeadJohnson (Enfamil) and PMB (maker of store-brand formulas sold at Target, Kroeger and others).

“We’re going to baby formula companies directly because we can’t wait for the FDA. Their track record concerning this toxic sex hormone has been horrible,” said Alex Formuzis, a spokesman for the group.

As yet, there has been no response from the companies, according to Formuzis.

In the meantime, the group recommends using powdered baby formula instead of liquid formula sold in metal cans.

Representative of the International Formula Council, which represents baby formula companies, have assured consumer groups that the industry follows the strictest of health standards and would pursue packaging alternatives.

Besides being used in food and formula can liners, bisphenol A is used to make hard, brittle, usqueezable polycarbonate plastic, commonly used in baby bottles, sippy cups, dishes and hikers’ water bottles. Nationwide, Safeway and some other stores have already removed polycarbonate baby bottles from their shelves in response to health concerns of parents and cities, including San Francisco.

The Chronicle/Lance Iversen/2007

Lucina Lippman gets a sip of milk out of a glass bottle from her dad, David.

Bisphenol A, which acts like estrogen in living organisms, is also an ingredient in some sealants used by some dentists to protect children from cavities. It’s also used to toughen casings of cell phones, laptops and automotive parts.

The FDA has come under fire recently from members of Congress who criticized the agency for hiring a private consulting group, ICF International, with strong industry ties to perform some of the analyses that the agency used in making a determination that bisphenol A is safe. The FDA said it looked into the matter, and didn’t have a problem with the consultant.

Last week, the Food and Drug Administration received a highly critical review from its own science advisory panel, the FDA Science Board Subcommittee on Bisphenol A, on how the FDA has assessed the safety of bisphenol A. The agency’s position has been that “there is a large body of evidence that indicates that FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects.”

However,the FDA’s advisory panel concluded that the FDA’s assessment that bisphenol A was safe was limited because it excluded a large number of studies.

The FDA’s assessment didn’t take into account the research considered by the National Toxicology Program and the National Institutes of Health, both federal programs.

In addition, the assessment lacked an adequate number of infant formula samples, and it averaged them all together instead of considering the effects of the high and low levels, the reviewers said.

The FDA’s assessment lacked a showing of the cumulative effects of bisphenol A, and showed only exposure resulting from the diet and not other routes of exposure, the reviewers said. And they criticized the assessment for not providing an adequate margin of error.

The FDA responded by saying, considering its advisors comments, it should further study the effects of bisphenol A.

FDA Commissioner Andrew von Eschenbach wrote an opinion piece Friday on the agency’s Web site saying he didn’t take the official review by the FDA Science Board Subcommittee on Bisphenol A as criticism. He said the agency is seeking new data and only then will it have a strong scientific foundation on which to make a regulatory decision.

At a press conference Friday, Frederick vom Saal, lead researcher and professor of biological sciences in the Endocrine Disruptors Group at the University of Missouri-Columbia, said he found it disturbing that the FDA said there was uncertainty over the safety of bisphenol A. There is “already massive literature showing harm,” including dozens of strong, peer-reviewed studies showing prostate, breast, heart and other damage in laboratory animals from low levels of bisphenol A.

The U.S. Centers for Disease Control and Prevention released an epidemiological study, which looks at the effects on humans, and found links between bisphenol A exposure and increased risk of Type 2 diabetes and heart and liver disease.

The California Senate passed a bill last session banning bisphenol A in baby bottles. But the measure fell a few votes short in the Assembly. The measure is expected to emerge again in the next session.

Manufacturers of bisphenol A lobbied heavily against the measure in Sacramento and in San Francisco. Their industry trade group, the American Chemistry Council, maintains that the chemical doesn’t leach out of products in high enough levels to cause health problems.

The manufacturer of the chemical is Polycarbonate/BPA Global Group, which represents five chemical companies, including Dow Chemical Co. and Bayer MaterialScience.